Dose-dependent effects of the Cimicifuga racemosa extract Ze 450 (drug simidona) in the treatment of climacteric complaints a randomized placebo-controlled study
Keywords:Cimicifuga racemosa, menopause, vasomotor symptoms, non-hormonal therapy, randomized study
Since large epidemiological studies with long-term hormonal replacement therapy have shown a small but significantly increased risk for the development of invasive breast cancer, there is an increasing interest in nonhormonal treatment modalities for patients with climacteric symptoms.
Cimicifuga racemosa is a perennial medicinal plant native to North America where it has been used for centuries in indigenous medicine for the treatment of various conditions. Extracts from Cimicifuga racemosa (CR, synonym Actaea racemosa) have shown efficacy in trials in women with menopausal symptoms. Yet, dose dependency remains unclear. Therefore, 180 female outpatients with climacteric complaints were treated for 12 weeks in a randomized, double-blind, placebo-controlled, 3-armed trial (CR extract Ze 450 in 6.5 mg or 13.0 mg, or placebo). The study took place in four outpatient clinics.
Primary outcome was the difference in menopausal symptoms (vasomotor, psychological, and somatic), assessed by the Kupperman Menopausal Index between baseline and week 12.
Secondary efficacy variables were patients’ self-assessments of general quality of life, responder rates, and safety.
Compared to placebo, patients receiving Ze 450 showed a significant reduction in the severity of menopausal symptoms in a dose-dependent manner from baseline to endpoint (mean absolute differences 17.0 (95% CI 14.65–19.35) score points, р < 0.0001 for 13.0 mg; mean absolute differences 8.47 (95% CI 5.55–11.39) score points, р = 0.0003 for 6.5 mg). Quality of life and responder rates corresponded with the main endpoint. Changes in menopausal symptoms and quality of life were inversely correlated. Reported adverse events and clinical laboratory testing did not raise safety concerns. The CR extract Ze 450 is an effective and well-tolerated nonhormonal alternative to hormone treatment for symptom relief in menopausal women.
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